Will vaginal microbicides be acceptable? Qualitative research explores opinions and preferences of women and men.

In developing a vaginal microbicide to protect against sexually transmitted infections (STIs), including HIV, scientists must consider not only the inherent effectiveness of any potential product but also whether women and men will use it and, if so, whether that use will be consistent. For this reason, investigators are using qualitative research methods, such as in-depth interviews and focus group discussions, to determine whether women and men are likely to accept such a product.

"Acceptability is going to influence use, which in turn will influence the overall effectiveness of any microbicide that is developed," says Dr. Cynthia Woodsong, an FHI senior scientist. Dr. Woodsong is leading the qualitative component of a vaginal microbicide acceptability study among male and female adult and teen clients at an STI clinic and a family planning clinic in North Carolina, USA.

With the development of vaginal microbicides, women would have a female-controlled method of protecting themselves from STIs. But, to be effective, "microbicides will need to be used consistently and correctly by women over a long period of time, so it will be important to ensure that women's views are seriously considered in the design, packaging, and promotion of these products," says Dr. Zeda Rosenberg, the chief executive officer of the International Partnership for Microbicides, currently based at FHI. "Qualitative research can help us understand women's concerns and perhaps shed some light on the behavioral factors that will influence a woman's decision to use or not to use a microbicidal product."

Researchers have pointed out that a less effective microbicide used more often could actually provide more protection than a more effective product (such as condoms) used less often. Analysts have noted, for example, that a method that is 30 percent efficacious yet used 60 percent of the time would provide more protection than a method that is 90 percent efficacious used only 20 percent of the time. (1)

"If a product is not acceptable, some people will not use it regardless of its efficacy," says Dr. Woodsong, whose U.S.-based study seeks to determine the acceptability of two over-the-counter vaginal lubricants: a gel and a suppository. These products contain no active ingredients to protect against STIs, but they have physical properties similar to vaginal microbicides under development. Funded by the U.S. National Institute of Child Health and Human Development, the study is being conducted in collaboration with the U.S.-based Research Triangle Institute.

The study began with in-depth interviews with 26 clinic staff--including physicians, nurses, counselors, translators, and receptionists--to obtain staff perceptions of client issues likely to influence vaginal microbicide use. This qualitative information helped researchers design questions for focus group discussions and in-depth interviews conducted later with 134 clients: 69 women who had tested the two vaginal lubricants with their partners and 65 men, some of whom were partners of the women in the study. These women and men (63 African Americans, 34 Hispanics, and 37 Caucasians) were asked about their impressions of the vaginal lubricants and the potential use of hypothetical future vaginal microbicides. Data gathered during this formative phase will be used later during the study's measurement and testing phase. (2)

Dr. Woodsong notes that "there was some interest in having a product that could enhance sex by providing a tingling sensation, or a pleasant taste or odor." The majority of study participants, however said they preferred a product with no color, odor, taste, or texture noticeable during or after sex. Participants noted that products would need to be packaged discreetly and be inexpensive to be used regularly.

Although most study participants found the idea of microbicide use acceptable, they described situations in which use could be difficult. "Individuals in casual relationships recognized their STI risk and thought that using an STI-prevention product such as a vaginal microbicide would be a good idea," says Dr. Woodsong. "But men and women said that they would be less likely to use a microbicide if they were in long-term relationships or were married. In these situations, microbicide use would imply that either they were unfaithful or that they suspected their partner was."

Clandestine use

Many experts have argued that development of a vaginal microbicide could enable women to protect themselves from STIs without their partners' knowledge. But multinational acceptability studies have identified differing opinions about covert use of such vaginal products. In a qualitative study by the New York-based Population Council of the acceptability of three nonoxynol-9 (N-9) spermicides used by 145 women from Cote d'Ivoire, Zimbabwe, Thailand, and the United States, roughly three-quarters of women participating in focus group discussions and structured interviews said that they preferred to tell their partners of spermicide use both during the study and in hypothetical future situations. (3)

Sometimes a vaginal product's characteristics, such as lubricating qualities, can affect whether women believe they will be able to use it clandestinely, according to research in which FHI collaborated. (4) The study used focus group discussions and diaries maintained by the study's female participants to evaluate the acceptability and use of a potential vaginal microbicide among women at low risk for STIs and among their partners in Malawi, Thailand, India, Zimbabwe, and the United States. After using the product, most women and their partners from all five countries said that clandestine use would be impossible because of its "wetness" or "messiness."

Other qualitative research, conducted by the Population Council and involving 12 focus group discussions with taxi drivers and farmers from Zimbabwe, Mexico, and the United States. indicated various degrees of partner discomfort with the idea of covert use of vaginal microbicides. (5) Study participants included 19 urban taxi drivers and 16 farmers from Zimbabwe; 21 urban taxi drivers and 20 farmers from Mexico; and 16 suburban taxi drivers and 14 farmers from the United States. During the study's focus group discussions:

* Zimbabwean taxi drivers acknowledged that their partners might be able to conceal microbicide use, but said they would be angry if they found out.

* Mexican taxi drivers agreed that women should not have to get their husbands' permission to use microbicides for protection against STIs, but said partner permission would be needed if the product were also a contraceptive.

* Mexican farmers felt that women needed partner permission for microbicide use regardless of the reason for its use.

* U.S. taxi drivers and farmers said their partners would not need their permission for microbicide use if the product caused no side effects for the men, but noted that they would like their partners to tell them about use.

Many of the men in this study wanted to be involved in the decision to use a vaginal microbicide. A microbicide acceptability study among a random sample of 243 South African men showed similar results. (6) Recruited from Durban STI clinics, a Pretoria university, and the general population of Cape Town and Durban, study participants were given a demonstration showing the consistency and amount of microbicidal gel likely to be inserted in a woman's vagina prior to sex. During interviews following the demonstration, more than 80 percent of the men said they wanted to be informed of a partner's choice to use a vaginal microbicide. Most also wanted to participate in the decision to use it, and added that they would be willing to pay for such a product.

Cultural differences

The development and introduction of culturally appropriate vaginal microbicides requires an understanding of the social and psychological factors that affect couples' sexual negotiations and risk-reduction behaviors within a particular culture. To this end, FHI researchers are conducting formative research that includes in-depth interviews with 30 women and 15 male partners in Pune, India, to explore how women and men form HIV and STI risk perceptions; how relationship dynamics affect women's ability to negotiate sex, condom use, and potential microbicide use; and when and why women do not reduce behaviors that endanger their reproductive health. Findings from this first research stage will be used to develop culturally appropriate measures of factors that influence microbicide acceptability and use. These measures will later be integrated into an assessment of microbicide acceptability and sustained use. (7)

"Little research exists to help us understand whether and how vaginal microbicides might be used, particularly by lower- and middle-class Indian married couples," says Elizabeth Tolley, an FHI senior research associate and coordinator of the study, which is being conducted in collaboration with the India-based National AIDS Research Institute and the US-based HIV Prevention Trials Network. "Women in these partnerships may have less power to negotiate risk-reduction behaviors such as condom or microbicide use than female sex workers involved in high-risk relationships."

Acceptability research also underscores the need to develop many types of vaginal microbicides to accommodate differing needs and conditions throughout the world. Microbicide acceptability research conducted among Zimbabwean, Mexican, and South African men, for example, found strong preferences for the development of microbicides without contraceptive properties. (8) This contrasts with the formative results of the US-based acceptability study, where men and women preferred microbicides that could protect against pregnancy as well as STIs.

Vaginal microbicidal products ideally will include those that provide vaginal lubrication as well as ones that do not. The US-based formative study found that many male and female study participants liked the extra lubrication the vaginal products provided. But, in Zimbabwe and South Africa, where "dry sex" is considered more pleasurable and healthy than "wet sex," male study participants have expressed concern that microbicides might cause excessive vaginal lubrication. (9) Similarly, the lubrication qualities of three vaginal products tested in a 2000 acceptability study conducted by FHI in conjunction with U.S.-based Abt Associates Inc. among 83 U.S. and Puerto Rican women at high HIV risk were unacceptable to some male partners of study participants from San Juan, Puerto Rico. Partner objections most commonly cited by Puerto Rican women during interviews were that the products were too "messy," decreased friction or sensation during intercourse, or detracted from sexual spontaneity. (10)

Product packaging will also need to be culturally appropriate if microbicides are to be used regularly. The majority of clients participating in the formative phase of the U.S.-based study, for instance, preferred products inserted with applicators to those requiring finger insertion. But Zimbabwean women in the N-9 spermicide acceptability study found applicator disposal problematic. (11) Several Zimbabwean study participants reported that they burned used applicators and packaging to avoid discovery by neighbors. Thai women in this study also worried about having to store spermicide suppositories in the refrigerator where other family members could see them.

It has been suggested that microbicide use in conjunction with diaphragm use might offer women greater HIV and STI protection than microbicide use alone. If so, regular, consistent microbicide use will rely as much on diaphragm acceptability as microbicide acceptability. For this reason. FHI is assisting researchers at the U.S.-based Contraceptive Research and Development (CONRAD) Program in a qualitative study to determine the ability and willingness of Brazilian commercial sex workers to properly and consistently use a diaphragm (with a lubricant) in their commercial and personal sexual relationships. "If women are not willing to use a diaphragm, then there is no point in promoting its use with a microbicide," says Lorie Broomhall, an FHI senior associate and project coordinator. Forty-five sex workers from Campinas, a suburb of Sao Paulo, are being recruited to participate in the study, which is being conducted in collaboration with the Centro de Pesquisas Materno--Infantis de Campinas (CEMICAMP) at the University of Campinas.

Sexual pleasure and condoms

For vaginal microbicides to be used regularly, qualitative research shows they must not interfere with sexual pleasure. In fact, some women from Cote d'Ivoire, Zimbabwe, Thailand, and the United States who participated in the N-9 spermicide acceptability study said they favored study spermicides that enhanced sexual pleasure. And some participants reported enjoying certain products because they, or their partners, perceived the products as "sexy." (12)

Qualitative research results also reveal that health care providers will face an ongoing challenge if and when vaginal microbicides become available. First-generation microbicides may only be 30 percent efficacious, making condom use still necessary for adequate protection against infection. But many men report disliking condoms. For example, condoms were found to be unpopular among over half of 243 South African men queried about their use during a vaginal microbicide acceptability study. (13) The most common reasons given for disliking condoms were that they caused a "loss of trust" between partners and were unnatural and uncomfortable. Nevertheless, providers of any vaginal microbicides that are developed will need to continue to promote condoms as the best protection against STIs, including HIV, and simultaneously inform clients of the limitations of microbicide effectiveness.

References

(1.) Watts CH, Thompson WA, Heise LL. The impact of microbicides for HIV prevention: results of a mathematical modeling exercise. 12th World AIDS Conference, Geneva, Switzerland, June 28-July 3, 1998.

(2.) Woodsong C, Koo H. A holistic model of microbicide acceptability. Microbicides 2002, Antwerp, Belgium, May 12-15, 2002.

(3.) Coggins C, Elias C, Atisook R, et al. A Study of Women's Preferences Regarding the Formulation of Over-the-Counter Vaginal Spermicides. Critical Issues in Reproductive Health Series. New York, NY: Population Council, 1998.

(4.) Bentley M, Morrow K, Fullem A, et al. Acceptability of novel, microbicide BufferGel during a Phase I safety trial in Thailand, India, Zimbabwe, and Malawi. AIDS 2001;15(suppl 1):S30; Bentley M, Morrow K, Fullem A, et al. Acceptability of a novel vaginal microbicide during a safety trial among low-risk women. Fam Plann Perspect 2000;32(4):184-88.

(5.) Coggins C, Blanchard K, Friedland B. Men's attitudes towards a potential vaginal microbicide in Zimbabwe, Mexico and the USA. Reprod Health Matters 2000;8(15):132-41; van de Wijgert J, Khumalo-Sakutukwa G, Coggins C, et al. Men's attitudes toward vaginal microbicides and microbicide trials in Zimbabwe. Int tam Plann Perspect 1999;25(1):15-20.

(6.) Ramjee G, Gouws E, Andrews A, et al. The acceptability of a vaginal microbicide among South African men. Int Fam Plann Perspect 2001;27(4):164-70.

(7.) Tolley E. Pilot study on acceptability of vaginal microbicides: development and validation of acceptability measures. Study protocol. Unpublished paper. Family Health International, 2002.

(8.) Coggins, Blanchard, Friedland; Ramjee.

(9.) Coggins, Blanchard, Friedland; Ramjee.

(10.) Hammett T, Mason T, Joanis C, et al. Acceptability of formulations and application methods for vaginal microbicides among drug-involved women' results of product trials in three cities. Sex Transm Dis 2000;27(2):119-26.

(11.) Coggins, Elias, Atisook.

(12.) Coggins, Elias, Atisook.

(13.) Ramjee.